Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·XACT CARTOID STENT SYSTEM

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·Protégé GPS Self-Expanding Peripheral Stent System, Protégé RX Carotid Stent System

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·CARTOID WALLSTENT MONORAIL ENDOPROSTHESIS

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·ENROUTE Transcarotid Stent System

Mitral Valve Repair Devices

FDA Pre-Market Approval

FDA Class 3 ·MitraClip™ G4 Clip Delivery System

050-00-00-MDR

Certificate

MDR QMS·NTC Srl·ITALCERT SRL

046-00-00-MDR

Certificate

MDR QMS·NTC Srl·ITALCERT SRL

040-00-00-MDR

Certificate

MDR QMS·NTC Srl·ITALCERT SRL

INSPIRE 7F M oxgenator with integrated arterial filter

FDA registration

SORIN GROUP ITALIA S.R.L·5 products·🇮🇹 Italy

Skypro, SP01 Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TYVEK STERILIZATION POUCHE

Basic UDI-DI

EU MDR · Eu Md Class 1 ·FTM AMBALAJ MEDİKAL İTH. İHR. SAN. VE TİC.LTD. ŞTİ·12 devices

DÜZ STERİLİZASYON POŞETİ

Basic UDI-DI

EU MDR · Eu Md Class 1 ·FTM AMBALAJ MEDİKAL İTH. İHR. SAN. VE TİC.LTD. ŞTİ·27 devices

Self-Adhesive Sterilization Pouch

Basic UDI-DI

EU MDR · Eu Md Class 1 ·FTM AMBALAJ MEDİKAL İTH. İHR. SAN. VE TİC.LTD. ŞTİ·1 device

GUSSET STERILIZATION REEL

Basic UDI-DI

EU MDR · Eu Md Class 1 ·FTM AMBALAJ MEDİKAL İTH. İHR. SAN. VE TİC.LTD. ŞTİ·8 devices

TYVEK STREILIZATION REEL

Basic UDI-DI

EU MDR · Eu Md Class 1 ·FTM AMBALAJ MEDİKAL İTH. İHR. SAN. VE TİC.LTD. ŞTİ·8 devices

FLAT STERILIZATION REELS

Basic UDI-DI

EU MDR · Eu Md Class 1 ·FTM AMBALAJ MEDİKAL İTH. İHR. SAN. VE TİC.LTD. ŞTİ·6 devices

CTM GmbH

Authorized representative

🇩🇪 Germany

ATM/p53/13q14/RB1/CSP12 gene Probe Detection Kit (fluorescence in situ hybridization )

Basic UDI-DI

EU IVDD · Eu Ivd General ·Wuhan YZY Medical Science and Technology Co., Ltd·1 device

QUADROX-i

FDA UDI

Maquet Cardiopulmonary AG·04037692009970·

QUADROX-i

FDA UDI

Maquet Cardiopulmonary AG·04037692009697·